On August 23, 2021, the US Food and Drug Administration (“FDA”) granted full approval for the Pfizer-BioNTech COVID-19 (“Pfizer”) vaccine for individuals sixteen-years-old and older. This change shifts the vaccine from emergency-use only and is the first COVID-19 vaccine granted approval by the FDA in the United States. For individuals aged twelve through fifteen, the Pfizer vaccine continues to be available under emergency use at this time. Likewise, the administration of a third dose is still available under emergency-use only.

Representatives from the FDA assured the public it “can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.” The FDA evaluated hundreds of thousands of pages of data and information included in the Pfizer manufacturer’s submission of its biologics license application. The director of FDA’s Center for Biologics Evaluation and Research stated the FDA’s “scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine” and felt confident that “although [the FDA] approved this vaccine expeditiously, it was fully in keeping with [its] existing high standards for vaccines in the U.S.” This “milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Norton Rose Fulbright lawyers will continue to provide relevant updates for healthcare providers on the Health Law Pulse during the COVID-19 public health crisis.